The European Commission has published a draft Commission Regulation (SANTE/1575/2025) proposing amendments to Regulation (EC) No 1925/2006 regarding the use of monacolins derived from red yeast rice in foods and food supplements.
Previously, under Commission Regulation (EU) 2022/860, the use of monacolins from red yeast rice was restricted to less than 3 mg per daily portion and placed under Union scrutiny due to safety concerns. The restriction was based on a 2018 scientific opinion from the European Food Safety Authority, which indicated that exposure to monacolins at intake levels as low as 3 mg per day could lead to serious adverse effects, particularly on the musculoskeletal system (including rhabdomyolysis) and the liver.
Following additional submissions from stakeholders and further evaluation, the European Food Safety Authority issued a new scientific opinion on 29 January 2025, concluding that the additional data did not demonstrate the safety of monacolins from red yeast rice at intake levels below 3 mg/day. EFSA also stated that it was not possible to identify a daily intake level that would be safe for the general population or vulnerable groups.
Based on this assessment, the draft regulation proposes to move monacolins from red yeast rice to Part A of Annex III of Regulation (EC) No 1925/2006, which lists substances prohibited for use in foods. As part of the amendment, monacolins would be removed from Part B (restricted substances) and Part C (substances under Union scrutiny) of the annex.
To allow a transition period for industry, foods containing monacolins from red yeast rice that were lawfully placed on the market before the entry into force of the regulation may continue to be marketed for 12 months after the regulation becomes applicable.
The proposed measure aims to protect consumer health in light of ongoing safety concerns associated with red yeast rice supplements commonly used for cholesterol management.
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